Principal Statistical Programmer (SAS/R) – Remote

Ue - Candidate Experience - España; Valladolid; A distancia; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) dedicated to a sponsor client. You will work independently with minimal supervision, leading reporting and analysis activities for pivotal clinical trials and overseeing CRO programmers to ensure timely, high-quality data deliveries.

Key tasks include developing SDTM and ADaM specifications, datasets, listings, tables and figures; creating SAS and R programs; supporting CSR and regulatory submissions; and ensuring

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies
• Develop SAS programs to generate datasets, complex listings, tables (including descriptive and inferential statistics) and graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs
• Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines
• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
• Provide review and

Descripción del empleo

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) dedicated to a sponsor client. You will work independently with minimal supervision, leading reporting and analysis activities for pivotal clinical trials and overseeing CRO programmers to ensure timely, high-quality data deliveries.

Key tasks include developing SDTM and ADaM specifications, datasets, listings, tables and figures; creating SAS and R programs; supporting CSR and regulatory submissions; and ensuring